CODMAN® HOLTER® RICKHAM® 821623Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10381780517788), received between Oct 5, 2022 and Aug 21, 2026 — classified as 7 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (6 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryAug 21, 2026Insufficient Device Problem Information

  This report is linked to MFG Report Numbers: (same patient - different events)3013886523-2025-00216 3013886523-2026-00195Study - BioMarin Cerliponase Alfa Observational Study"On an unspecified date, the participant underwent implantation of Intracerebroventricular device (ICV) set (Codman Rickman ICV device; model number 82-1623). The lot number was not reported.""On (b)(6) 2017, the participant was initiated on treatment with Brineura (300 milligram, qow, Intracerebroventricular use). The lot number for Brineura was M006590. The most recent dose was administered on 03-JUL-2026.""On (b)(6) 2019, the participant again had an ICV set implanted.""On (b)(6) 2026 at 08:22, the participant experienced Grade 1 device related infection. Prior to the infusion, on (b)(6) 2026, the participant's CSF culture was obtained. On (b)(6) 2026, preliminary results of the culture indicated Cuti bacterium (formerly Propionibacterium) acnes in thioglycolate broth only. On (b)(6) 2026, final results of the CSF culture indicated Cuti bacterium (formerly Propionibacterium) acnes in thioglycolate broth only. The outcome of the event was reported as Recovering/Resolving.

  Patient problems: Unspecified Infection

  MAUDE report 50374211 ↗
• InjuryAug 7, 2026Insufficient Device Problem Information

  Medwatch Number: (b)(4). "The participant's past medical history included: SARS-CoV-2 antibody test positive, and Drug delivery device placement. The participant's concurrent conditions included: Dysarthria, Intellectual disability, Gait disturbance, Muscle spasticity, Knee deformity, Neuronal ceroid lipofuscinosis, Blood cholesterol decreased, Ataxia,Carotid pulse, and Hypertonia. No allergies were reported. Concomitant medications included: Levetiracetam, Gemfibrozil, Nutrients nos, and Trihexyphenidyl hydrochloride. Paracetamol, Cetirizine hydrochloride, Lidocaine hydrochloride, Ondansetron hydrochloride, Rifampicin, Vancomycin hydrochloride, and Ibuprofen were used as premedication for the participant's Brineura infusions." "On (b)(6) 2017, the participant was initiated on treatment with Brineura (300 milligram, qow, intracerebroventricular). The lot number for Brineura was M006590. The most recent dose was administered on (b)(6) 2026." "On (b)(6) 2018, the participant underwent implantation of an intracerebral ventriculostomy (ICV) set (Codman & Shurtleff; Rickham model number 82-1623). The lot, serial, catalogue and UDI numbers were not reported." "On (b)(6) 2026, the partici

  Patient problems: Bacterial Infection

  MAUDE report 50175251 ↗
• InjuryAug 7, 2026Insufficient Device Problem Information

  Patient problems: Unspecified Infection

  MAUDE report 50175249 ↗
• InjuryJan 7, 2026Leak/Splash

  N/A.

  Patient problems: Insufficient Information

  MAUDE report 23988175 ↗
• InjuryJan 2, 2026Insufficient Device Problem Information

  BIOMARIN STUDY (CERLIPONASE ALFA OBSERVATIONAL STUDY). THIS CASE IS A REPORT REFERRING TO A 21 YEAR OLD MALE PATIENT. THE PARTICIPANT'S CONCURRENT CONDITION INCLUDED NEURONAL CEROID LIPOFUSCINOSIS. "ON (B)(6) 2017, THE PARTICIPANT WAS INITIATED ON TREATMENT WITH BRINEURA (300 MILLIGRAM, QOW, INTRACEREBROVENTRICULAR). THE LOT NUMBER FOR BRINEURA WAS M006035. THE MOST RECENT DOSE WAS ADMINISTERED ON (B)(6) 2025." "ON (B)(6) 2018, THE PARTICIPANT UNDERWENT IMPLANTATION OF RICKHAM INTRACEREBRAL VENTRICULOSTOMY (ICV) SET (MODEL NUMBER 82-1623). THE LOT NUMBER WAS NOT REPORTED." "ON (B)(6) 2025 AT 08:45, THE PARTICIPANT EXPERIENCED GRADE 1 DEVICE RELATED INFECTION WITH A POSITIVE CSF CULTURE. ON THE SAME DATE, THE PARTICIPANT'S CEREBROSPINAL FLUID (CSF) WAS COLLECTED AND ANALYSIS SHOWED RARE WHITE BLOOD CELLS, AND NO ORGANISM WAS SEEN. ON (B)(6) 2025, RESULTS SHOWED CUTIBACTERIUM (FORMERLY PROPIONIBACTERIUM) ACNES IN THIOGLYCOLATE BROTH. ON (B)(6) 2025, CUTIBACTERIUM (FORMERLY PROPIONIBACTERIUM) ACNES IN THIOGLYCOLATE BROTH WAS POSITIVE. NO TREATMENT WAS GIVEN FOR THE EVENT. NO ACTION WAS TAKEN WITH BRINEURA DUE TO THE EVENT. THE DEVICE WAS OPERATED BY THE NEUROSURGEON AND WAS NOT AVAILA

  Patient problems: Bacterial Infection

  MAUDE report 23942767 ↗
• InjuryOct 24, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  THIS IS 2 OF 2 REPORTS LINKED TO MFG REPORT NUMBERS: 3013886523-2023-00348 BIOMARIN STUDY: CERLIPONASE ALFA OBSERVATIONAL STUDY. CASE DESCRIPTION: THIS CASE REFERS TO A 20 YEAR-OLD MALE SUBJECT. "ON (B)(6) 2018, THE PARTICIPANT UNDERWENT IMPLANTATION OF INTRACEREBRAL VENTRICULOSTOMY (ICV) SET CODMAN RICKHAM; MODEL NUMBER 82-1623. THE LOT NUMBER WAS NOT REPORTED." "ON (B)(6) 2024 AT 07:40, THE PARTICIPANT'S CEREBROSPINAL FLUID (CSF) TESTING WAS PERFORMED, AND RARE WHITE BLOOD CELLS WERE OBSERVED; HOWEVER, NO ORGANISM WAS SEEN. THE PARTICIPANT EXPERIENCED A GRADE 1 DEVICE RELATED INFECTION. ON THE SAME DATE, VANCOMYCIN HYDROCHLORIDE WAS GIVEN PRE-INFUSION AND THEN THE PARTICIPANT HAD HIS BRINEURA INFUSION. ON (B)(6) 2024, THE CSF COLLECTED ON (B)(6) 2024 TESTED POSITIVE FOR RARE CURTIBACTERIUM (FORMERLY PROPIONIBACTERIUM) ACNES. CSF WAS AGAIN COLLECTED ON (B)(6) 2024 (NO RESULTS REPORTED) AND TESTED NEGATIVE ON 30-SEP-2024. NO TREATMENT FOR THE EVENT WAS REPORTED. NO ACTION WAS TAKEN WITH BRINEURA DUE TO THE EVENT." "THE OUTCOME OF THE EVENT WAS REPORTED AS RECOVERED/RESOLVED ON 26-SEP-2024 AT 09:12." "THE INVESTIGATOR ASSESSED THE EVENT OF "DEVICE RELATED INFECTION" AS NOT RELATED T

  Patient problems: Bacterial Infection

  MAUDE report 20524701 ↗
• InjuryOct 5, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  CLINICAL STUDY ( BIOMARIN SPONSORED STUDY, CERLIPONASE ALFA OBSERVATIONAL STUDY): THIS CASE IS A REPORT REFERRING TO A 7 YEARS-OLD MALE SUBJECT. ON (B)(6) 2018, THE SUBJECT UNDERWENT IMPLANTATION OF CODMAN RICKHAM ICV DEVICE (MODEL 82-1623). THE LOT NUMBER AND SERIAL NUMBER WERE NOT REPORTED. ON (B)(6) 2018, THE SUBJECT INITIATED TREATMENT WITH BRINEURA (300 MILLIGRAM, QOW, INTRACEREBROVENTRICULAR). THE LOT NUMBER FOR BRINEURA WAS L241207. THE MOST RECENT DOSE WAS ADMINISTERED ON (B)(6) 2022. ON (B)(6) 2022 AT 10:00, THE SUBJECT EXPERIENCED GRADE 1 DEVICE RELATED INFECTION (DEVICE RELATED INFECTION). ON (B)(6) 2022, THE SUBJECT HAD A CSF CULTURE COLLECTED THAT REVEALED RARE WHITE BLOOD CELLS AND NO ORGANISMS SEEN. THE POSITIVE CSF RESULT WAS CONFIRMED ON (B)(6) 2022 WHEN THE CSF CULTURE REVEALED RARE GRAM IN THIOGLYCOLATE BROTH ONLY. THE DEVICE WAS NO REPLACED AND NO TREATMENT WAS GIVEN. NO ACTION WAS TAKEN WITH BRINEURA DUE TO THE EVENT. THE OUTCOME OF THE EVENT WAS REPORTED AS RECOVERING/RESOLVING. BIOMARIN HAS ASSESSED THE EVENT AS MEDICALLY SIGNIFICANT. THE INVESTIGATOR ASSESSED THE EVENT OF DEVICE RELATED INFECTION AS NOT RELATED TO TREATMENT WITH BRINEURA. THE INVESTIGATOR AS

  Patient problems: Unspecified Infection

  MAUDE report 15545945 ↗